Dinah, ClinkShrink, & Roy produce Shrink Rap: a blog by Psychiatrists for Psychiatrists. A place to talk; no one has to listen.
All patient vignettes are confabulated; the psychiatrists, however, are mostly real.
--Topics include psychotherapy, humor, depression, bipolar, anxiety, schizophrenia, medications, ethics, psychopharmacology, forensic and correctional psychiatry, psychology, mental health, chocolate, and emotional support ducks. Don't ask. (It's not Shrink Wrap.)

Tuesday, August 22, 2006

Most psychiatrists know the story of how lithium was discovered, but for the rest of you here's the story:

Many years ago a fellow by the name of John Cade decided to give lithium to manic patients because he noticed that the substance seemed to calm agitated guinea pigs. (Don't ask me how he could tell the guinea pigs were agitated. As far as I can tell all guinea pigs do is squeak and munch alfalfa pellets, or occasionally chuckle while peeing on the visitor's lap but that's a story for another day.) Anyway, the lithium worked.

In the early '70's lithium was tried on another group of research subjects---prisoners with a history of violence. Researchers found that lithium cut the rate of violent infractions in half---even when the inmates didn't think the medication was working.

But the point of this post isn't specifically about lithium---we already have a nice post about that (Peace and Lithium). The topic of this post is clinical research on prisoners.

When this topic comes up most people have an immediate association to Josef Mengele and other horrors. However in the United States physicians had been doing research on prisoners for at least twenty years before that. In one study done in 1916 inmates on a prison farm were used to study pellagra, a disease caused by a nutritional deficiency of Vitamin B. In exchange for a full pardon they were placed on a four month diet entirely free of Vitamin B. By the end of the study half of them had developed dermatitis, weight loss, loss of strength and nervous system impairments.

By 1948 as a result of the Nuremberg trial America developed the earliest standards for human research on prisoners. Dr. Andrew Ivy, a prosecution expert at Nuremberg, proposed that medical research should be allowed if results were "unprocurable by other methods" and animal experimentation had already been performed. He also suggested that medical personel should serve as subjects along with volunteer prisoners. Although he recognized the potentially coercive influence of pardons or "good time" credit, he fell short of banning it outright as an incentive for participation.

At one time a central issue in correctional research was whether or not inmates truly had the capacity to give informed consent. The nature of the correctional environment was thought to be too coercive for completely voluntary consent given the lack of contact with advocates (including friends and family) or other counsel. Today this is not the prevailing opinion and inmates routinely give informed consent for treatment or research.

Presently correctional research is governed by the Code of Federal Regulations, Subpart C, entitled Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners As Subjects. These regulations permit research on prisoners if it falls within certain guidelines. The research must not give the subject advantages or opportunities within the prison to the extent that the offered reward would impair his ability to weigh the risks of the research. Subject selection must be impartial and free from influence by prison officials. Correctional research is allowed if it involves the study of the causes and effects of incarceration or criminal behavior, or conditions which affect prisoners as a class such as hepatitis or drug addiction. It is also allowed if it involves practices which have a reasonable probability of improving the health and well-being of the individual. All studies require that the research involve no more than minimal risk or inconvience to the inmate and that the decision to participate should not affect eligibility for parole or parole decisions. As with any human research, the study must be approved by an Institutional Review Board.

Now a New York Times article discusses a proposal to loosen Federal regulations for the use of prisoners in clinical drug trials. The proposal has the backing of a consortium of prison advocates, researchers, correctional staff and ex-offenders. Even the ACLU has signed on. But is this a good thing? Read the full story for the viewpoint of ex-research subject-prisoners. Be sure to watch the six minute video clip about the history of prisoner research in one Pennsylvania facility.

**********

You wouldn't believe how long it took to find this guinea pig picture. Along the way I found an unfortunate number of photos of guinea pigs as...umm...food. With apologies to our South American readers: yuck. Then I found this site with guinea pigs dressed in little costumes. How humiliating. Which would I prefer if I were a guinea pig?

Dinah, I never saw your picture. Apparently we were both editing my post at the same time---I got a weird error message when I was trying to upload it. I fixed the typographical error, thanks for pointing it out.

Fat Doctor! Thanks for stopping by. ShrinkRap's been thinking of you. If you're about to go NPO just forget anything I mentioned about guinea pigs and food. Then again, thinking about guinea pigs as food may help you go NPO.

That guinea pig site is too weird. Ok, I have to admit, I dressed up my pet guinea pig when I was a kid (she couldn't come to the tea party without her hat!) But I didn't treat it like a friggin barbie doll.

I'm guessing you'll get more comments about the guinea pig costumes than lithium.

I'm going to take a stab a this testing prisoners topic. This really doesn't sit well with me. There are too many questions.

I think I have a handle of the regulations if it is a federally funded study. But, what if it is a privately funded study, by, say, a pharmaceutical company? Would it still be as stringently regulated? Or, would they have free reign to do whatever they wanted?

The NY Times article had this interesting passage: On the issue of compensation for inmates, the report raised concern about “undue inducements to participate in research in order to gain access to medical care or other benefits they would not normally have.” It called for “adequate protections” to avoid “attempts to coerce or manipulate participation.’’

Good point about informed consent. Can adequate informed consent be obtained from prisoners?

Finally, I see a wide open door for litigation of everyone involved for potential side effects of research. No wonder the ACLU is behind this idea -- more business for them.

San Diego is known to pride itself as a city of research, with competing universities, prominent NIH institutes and cancer centers, as well as numerous private facilities. A weekly tabloid here that attempts to mimic NYC's Village Voice contains pages of ads soliciting physical medicine & psychiatric "subjects."

A colleague I worked with at a downtown clinic for the persistently mentally ill accepted a position in a clinical trials business (and a business it is). His facility does not deal with experimental medications, but attempts to enhance the indications of FDA approved medications.

Who are his patients? Not surprisingly, the same patients we had as clinic patients. Why? They are transported for free, they are paid to participate, they can get cigarettes & food, and some even choose studies which have an in-patient stage that can last several weeks (and, of course, pays more). Some go to the beach, others join clinical trials. It's like a paid vacation from the streets... with meds.

Given the compliance problems that one could expect from undomiciled trial subjects, it would seem to me that more variables could be controlled with "captive subjects." While I have my ethical concerns in regard to both groups, they seem more similar than not.

foofoo brings up a point I was thinking on ... it may well be that prisoners are a too controlled population. Humans in free society behave in certain random ways that may well be missing in the prison population. How do we know that those random ways are unimportant?

Most of these papers hanging on my wall say Engineer, specialist in quality assurance. Most of my time was spent using statistics to figure things out. I have a hard time with interfering with randomness and using prisoners does indeed interfere with randomness.

I've long thought that most of the mistakes in medicine were brought about by using a non-random clinical testing population.

----------My mother in law used to breed guinea pigs: My wife's horse used to break free and let all the guinea pigs out of their cages. The guinea pigs seemed to adore driving the chickens nuts. Gotta watch those guinea pigs! They have a badly warped sense of humor.

My thought on this is that clinical research is necessary to advance our approach to inmate care. While free society research obviously is relevant, it's also clear that free society research subjects are not the same group of people as who you find in a correctional facility. We have more comorbidity (Axis I and II), more substance abuse, more cognitive impairment, more co-existing medical conditions, fewer social supports and on and on. We have a group of patients that is harder to treat and less "pure" than your basic homogenous free society research pool. This is why the APA set up the Practice Research Network to study 'real world' treatment results.

Also, if you want to learn about the effects of confinement that kind of has to be done in a correctional environment with real inmates. (And no, I don't count the Zimbardo experiment as a real correctional study.)

But yes, external protections and close monitoring of clinical trials are essential. At the risk of sounding like the Wicked Witch of the West, 'these things must be done carefully'.

Your guinea pig site is cute....obviously you are spending too much time surfing the net tho... Some time I will get my blogspot going. Spending too much time on my myspace website! (http://www.myspace.com/momandpop)

This is really annoying. I posted a long comment and it disappeared. As bad as myspace!! Yes, you have to be young for myspace. There is a big Goat Band show in Hudson this week. I will try to find more guinea pig pictures.